All the pieces in place for OraSure

Epitope Inc.'s OraSure oral specimen collection device for HIV testing was approved in December 1994. But the true test of the marketability of the product is only now about to occur, as the FDA last week cleared for marketing EPT's companion Western Blot test.

Until now, if the initial OraSure test was positive, patients were required to provide a blood sample for a confirmatory test. The new test will be part of a package, using a single oral sample, called oral mucosal transudate, for both the initial and confirmatory tests. Oral mucosal transudate contains high concentrations of antibodies...